Single use medical devices

ABSTRACT

A single use medical device can include a single use medical device module configured for use in a medical procedure. The single use medical device can also include an electronic component having a one-time programmable (“OTP”) component that is configured to render the single use medical device module unusable after being used in the medical procedure in the subject. The single use medical device can also include a self-sacrificing module (SSM) that is configured to self-destruct and render the single use medical device unusable upon being cleaned or sterilized after being used in the medical procedure in the subject. The SSM can be operably coupled with a system controller module (SCM), which can read the state of the SSM and determine whether or not the medical device has undergone cleaning or sterilization.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This patent application is a continuation-in-part of U.S. applicationSer. No. 13/094,415 filed Apr. 26, 2011, which claims priority toprovisional patent applications U.S. Ser. No. 61/328,955, filed Apr. 28,2010, and U.S. Ser. No. 61/330,954, filed May 4, 2010, whichapplications are incorporated herein by specific reference in theirentirety.

BACKGROUND

The term “single-use” in medical devices means that a device orcomponent is discarded as waste after a single usage on a patient, andnot used again. Single-use medical devices offer critical benefits forpatients and also healthcare providers by eliminating the burden ofreprocessing single-use devices (“SUD”), and reducing the risk ofinfection from potential contaminations. With advances in technology andmaterials, SUDs are becoming practical both economically andlogistically.

Particularly, multi-use devices become contaminated with each use andare typically subjected to a sterilization procedure after each use toeliminate the contamination. Sterilization procedures can be burdensomeand are not always 100% effective. Any contaminant remaining on themulti-use device after the sterilization procedure can potentially causean infection in a patient on whom the multi-use device is subsequentlyused. In comparison, SUDs are only used during a single procedure on asingle patient, and thus generally do not get exposed to contaminationduring prior usage.

On the other hand, since SUDs are not re-used, the cost of a single-usedevice cannot be spread across multiple patients. However, recentadvances in technology and materials have made SUDs an economically andlogistically practical alternative to multi-use medical devices.

SUMMARY

In one embodiment, a single use medical device can be configured for useon a subject receiving a medical procedure. The single use medicaldevice can include a self-sacrificing module (SSM) that is configured toself-destruct and render the single use medical device unusable uponbeing cleaned or sterilized after being used in the medical procedure inthe subject. In one aspect, the SSM is operably coupled with one or moreelectronic components in the single use medical device. In one aspect,the SSM is operably coupled with a system controller module (SCM). Inone aspect, the SSM is operably coupled to a ground electronic line. Inone aspect, the SSM is located within an electronic circuit of thesingle use medical device and activation of the SSM causes an electroniccircuit to open. In one aspect, the SSM is operably coupled to a groundelectronic line and a clock line, when inactivated the SSM does notelectronically couple the ground electronic line and/or clock line, whenactivated the SSM electronically couples the ground electronic lineand/or clock line. In one aspect, any data line or electronic line, suchas a line that carriers a signal or data or power, can be usable beforethe SSM is activated, and then rendered unusable after the SSM isactivated, which can include coupling such a line to the ground asdescribed similarly to the clock line. Grounding a functional line bythe SSM can be used to disable the system and prevent further uses. Inone aspect, the SSM can be configured to function as a clock-timerlockout. However, in other embodiment, the activation of the SSM mayopen such a line to open a circuit to disable communication of signals,data, and/or power, thereby disabling the system.

In one embodiment, the SSM can include a biasing mechanism that has abiasing element and first and second electrically conductive elementsspaced apart by the biasing element. When the SSM is inactivated thefirst electrically conductive element does not electronically couplewith the second electrically conductive element, when the SSM isactivated the biasing element electronically couples the firstelectrically conductive element with the second electrically conductiveelement. In one aspect, the SSM includes a degradable member positionedbetween the first electrically conductive element and the secondelectrically conductive element, when the degradable member degrades,the biasing element electronically couples the first electricallyconductive element with the second electrically conductive element. Inone aspect, the degradable member degrades in response to heat,ionization, chemicals, liquid, aqueous solution, or radiation.

In one embodiment, the SSM includes an electrically conductivedegradable member positioned between and electrically coupling a firstelectrically conductive element and a second electrically conductiveelement. When the conductive degradable member degrades, the firstelectrically conductive element electrically uncouples with the secondelectrically conductive element. In one aspect, the SSM includes abiasing element biased against the electrically conducive degradablemember. When the SSM is activated the biasing element breaks theelectrically conductive degradable member so that the first electricallyconductive element is not electrically coupled with the secondelectrically conductive element. In one aspect, the electricallyconductive degradable member degrades in response to heat, ionization,chemicals, liquid, aqueous solution, or radiation.

In one embodiment, the SSM includes an electrically conductive memberhaving an electrically conductive state and an electricallynon-conductive state. The electrically conducive member can bepositioned between and electrically coupling a first electricallyconductive element and a second electrically conductive element. Theelectrically conductive member changes from the electrically conductivestate to the electrically non-conductive state when exposed to achemical. When in the electrically non-conductive state the firstelectrically conductive element is electrically uncoupled from thesecond electrically conductive element.

In one embodiment, the single use medical device can include a one-timeprogrammable (“OTP”) component that is configured to render the singleuse medical device module unusable after being used in the medicalprocedure in the subject, the OTP component being operably coupled withthe SCM. In one aspect, the SCM is configured to monitor the SSM andupon detecting a change in the SSM, the SCM causes the OTP component tobe programmed so that the single use medical device is unusable.

In one embodiment, the single use medical device is a handle or a basethat is operably coupleable to a single use medical device moduleconfigured for use within a body of a subject receiving a medicalprocedure. Here, a base is often part of an electronic device or systemthat is retained or mounted to a table top or a shelf top. Such a deviceor system with a base may or may not be portable. Accordingly, theconcepts and embodiments of the present invention are not limited tohandheld devices, but can be applied to larger systems and devices, suchas those that are not portable. As such, the base may be configured intoa single use device or a device with a predetermined number of uses orpredetermined number of sterilization or cleaning cycles. In fact, anyelectronic device that may become contaminated through routine use, suchas any electronic device used in an emergency room, operating room,contamination room, sterilization room, room with pathogens, or anyother room may be considered to include the OPT component and/or SSM andoperate as a single use device or a device with predetermined number ofuses. Often, the SCM can be included in any of these types of devices,with or without the OTP component, and/or with or without the SSM.

In one embodiment, the single use medical device is configured for usewithin a body of a subject receiving a medical procedure.

In one embodiment, the SSM can include an ethylene oxide sensor operablycoupled with the SCM. The SCM can be configured to monitor the SSM andupon detecting a change in the SSM, the SCM causes the OTP component tobe programmed so that the single use medical device is unusable.

In one embodiment, a medical device can include a system controllermodule (SCM) and a one-time programmable (“OTP”) component that isconfigured to render the single use medical device module unusable afterbeing used in the medical procedure in the subject, with a single usemedical device module configured for use within a body of a subjectreceiving a medical procedure. The medical device can be used in amethod of operating the medical device. Such a method can include:initializing the medical device with the SCM; reading data from the OTPcomponent; and determining whether the data from the OTP componentindicates the medical device has been used. If the medical device hasbeen used, then the medical device provides notification of such use,and then the SCM programs the OTP component such that the medical deviceis prevented from being used. If the medical device has not been used,then the SCM programs the OTP component to indicate that the medicaldevice has been used.

In one embodiment, a medical device can include a system controllermodule (SCM) and a one-time programmable (“OTP”) component that isconfigured to render the single use medical device module unusable afterbeing used in the medical procedure in the subject, with a single usemedical device module configured for use within a body of a subjectreceiving a medical procedure. The medical device can be used in amethod of testing the medical device. Such a method can include:initializing the medical device with the SCM; reading data from the OTPcomponent; and determining whether the data from the OTP componentindicates the medical device has been used. If the medical device hasbeen used, then the medical device provides notification of such use,and the medical device is prevented from being used. If the medicaldevice has not been used, then the SCM tests other components of themedical device for functionality. If the other components of the medicaldevice fail the test, then the medical device provides notification ofsuch failure, and the medical device is prevented from being used. Ifthe other components of the medical device pass the test, the medicaldevice is determined to be usable.

In one embodiment, the OTP component is selected from the groupconsisting of a standalone chip, embedded in another chip, on a circuitboard with the SCM, on a circuit board that does not include the SCM,embedded with SCM, integrated with a sensor, or combination thereof.

In one embodiment, the OTP component is operably coupled to a firstelectronic component having a first function in the device, andprogramming of the OTP component renders the first electronic componentincapable of performing the first function.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

The foregoing and following information as well as other features ofthis disclosure will become more fully apparent from the followingdescription and appended claims, taken in conjunction with theaccompanying drawings. Understanding that these drawings depict onlyseveral embodiments in accordance with the disclosure and are,therefore, not to be considered limiting of its scope, the disclosurewill be described with additional specificity and detail through use ofthe accompanying drawings, in which:

FIG. 1 includes a schematic diagram of an embodiment of a medical devicethat includes a reusable portion and a single use portion;

FIG. 1A includes a schematic diagram of an embodiment of a medicaldevice where the handle is also a single use device, which shows thatthe OTP component can be an element that is embedded or be an integralpart in one of the chips on circuit board, or be a separate standalonechip on the circuit board, or on a different circuit board;

FIG. 2 includes a schematic diagram of an embodiment of electroniccomponents of the medical device of FIG. 1, where the schematic diagramillustrates electronic components in the reusable portion and electroniccomponents in the single use portion;

FIG. 3 includes a flow diagram of an embodiment of a process of a singleuse medical device that inhibits reuse of the single use medical device;

FIG. 3A includes a flow diagram of an embodiment of a process of asingle use medical device that inhibits reuse of the single use medicaldevice;

FIG. 3B includes a flow diagram of an embodiment of a process of asingle use medical device that determines whether or not the single usemedical device is in condition for use;

FIG. 4 includes a schematic diagram of an embodiment of a medical devicethat includes a reusable portion and a single use portion;

FIG. 5 includes a schematic diagram of an embodiment of a single usecircuit that can be used in a single use portion of a medical device;

FIG. 6 includes a schematic diagram of an embodiment self-sacrificialcomponent of a single use medical device;

FIG. 6A includes a schematic diagram of an embodiment self-sacrificialcomponent of a single use medical device;

FIG. 6B includes a schematic diagram of an embodiment self-sacrificialcomponent of a single use medical device;

FIG. 7 includes a schematic diagram of an embodiment of a single useprinted circuit board and corresponding signals;

FIG. 8 includes a schematic diagram of another embodiment of a singleuse printed circuit board and corresponding signals;

FIG. 9 includes a schematic diagram of another embodiment of electroniccomponents of the medical device of FIG. 1, where the schematic diagramillustrates electronic components in the reusable portion and electroniccomponents in the single use portion;

FIG. 9A includes information for status bits that can be programmed intothe OTP;

FIG. 10 includes a schematic diagram of an embodiment of a sensor chiphaving a OTP component and other components;

FIG. 11 includes a schematic diagram of an embodiment of a process fordisabling the sensor chip of FIG. 10;

FIG. 12 includes a schematic diagram of an embodiment of a process fordisabling the sensor chip of FIG. 10; and

FIG. 13 includes a schematic diagram of an embodiment of a process fordisabling sensor chip of FIG. 10, and FIG. 14 includes an examplecomputing device that can be used with embodiments described herein,

FIG. 14 arranged in accordance with at least one of the embodimentsdescribed herein, and which arrangement may be modified in accordancewith the disclosure provided herein by one of ordinary skill in the art.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented herein. It will be readily understood that the aspects of thepresent disclosure, as generally described herein, and illustrated inthe figures, can be arranged, substituted, combined, separated, anddesigned in a wide variety of different configurations, all of which areexplicitly contemplated herein.

Generally, the present invention is related to single use medicaldevices that will only work one time in a medical procedure. After it isused in a medical procedure, the medical device has a single useelectronic component that either self-destructs or it renders themedical device unable to be used. The single use electronic componentcan include hardware and/or software configured to render the medicaldevice unable to be used after it is used in a medical procedure. Themedical device can be exemplified by an optical endoscope that has thesingle use electronic components in a disposable portion, such as theportion that is inserted into a patient for an endoscopic procedure, orin any portion, such as the handle, endoscope, catheter, or the like.The single use feature (e.g., one time use) can be located on thedisposable portion of the medical device, such as the portion that isinserted within a body, or may be located in any portion or component ofthe medical device to render that portion or component unusable after asingle use or render all of the components unusable after a single use.

The present invention includes a portion or a medical device that isreusable and one or more portions of the medical device that are singleuse. The single use portions are configured to be inoperable after beingused one time in a medical procedure (e.g., during actual use in amedical procedure, which does not include testing). The inoperabilityresults in the single use portion being rendered useless after thesingle use.

A single use medical device can include a single use medical devicemodule configured for use within a body of a subject receiving a medicalprocedure. The single use medical device module can include anelectronic component having a one-time programmable (“OTP”) componentthat is configured to render the single use medical device moduleunusable after being used one time in the medical procedure in thesubject. Optionally, the electronic component includes an image sensor,such as a CMOS sensor. However, the electronic component can be any typeof electronic component or chip in the medical device. In one aspect,the OTP component is operably coupled with the electronic component. Inan alternative aspect, the OTP component is embedded in anotherelectronic component. In one aspect, the OTP component is configured tooperate one time, and thereafter it does not allow the single usemedical device to operate. In one aspect, the system includes aself-sacrificing module (SSM) that self-destructs after being used onetime. In one aspect, the OTP component is operably coupled with a timerand an AND circuit, when the timer reaches a certain time, the singleuse medical device no longer works.

In one embodiment, the OTP component includes a disabling bit (DB)circuit that is programmed to disable the single use medical device whena Clock_out signal is received by the CMOC chip. The DB bit can includecircuit logic within the OTP chip that can disable the Cloc_in signal.

In one embodiment, the OTP component is configured to control variouselectronic components of the medical device within the single usemedical device module. In one aspect, the OTP component is configured tobe programmed one time by various electronic components of the medicaldevice within the single use medical device module. In one aspect, theOTP component is configured such that a state change of a signal to theOTP component disables the single use medical device module. In oneaspect, the single use medical device can include or be operably coupledwith a controller configured to program the OTP with data, such as asystem time stamp and an ID generated from Patient ID. The controllercan be configured to read the serial number of one or more electronicsmodules of the single use medical device module. The controller can beconfigured to tag a serial number of one or more electronics modules ofthe single use medical device module, and associate the serial numberwith a Patient ID.

In one embodiment, the electronic component having the OTP componentincludes an algorithm that is processed in order to render the singleuse medical device module unusable after being used in the medicalprocedure in the subject. The algorithm can be configured to processdata in order to detect and/or determine if the OTP component has beenprogrammed.

The single use medical device module can be configured to disable animage sensor by one or more of the following: disabling a clock (CLK) toa chip of the image sensor, the chip being operably coupled with the OTPcomponent; disabling a digital enabling D_en inside the image sensor; orchanging a state of the OTP component with “self-destroy” codes.

In one embodiment, a medical device can include a reusable portion, anda single use portion. The single use portion can include the single usemodule. The medical device can include a reusable portion and a singleuse portion, with the reusable portion removably receiving the singleuse portion. The single use portion can include a single use medicaldevice module configured for use within a body of a subject receiving amedical procedure having an electronic component having the OTPcomponent that is configured to render the single use medical devicemodule unusable after being used in the medical procedure in thesubject. The single use medical device can be used in a method thatincludes: using the single use portion; programming the OTP component;and terminating use of the single use portion. Once used, the single usemodule is inoperable. Once programmed, the OTP component is renderedinoperable and any electronic components or modules associated with theOTP component are rendered inoperable. The method can further includeattempting to reuse the single use portion, the single use portion beingunusable once the OTP component is programmed. The method can includethe single use portion providing an indication that the single useportion has already been used or that the single use portion is notoperational.

In one embodiment, a method of using a medical device with an OTPcomponent can include: generating a first unique case identifiercorresponding to a first unique patient undergoing a medical procedure;obtaining a first time stamp representing a current time; anddetermining that the OTP component has previously been programmed with asecond unique case identifier and a second time stamp, when the firstunique case identifier is different than the second unique caseidentifier, or when the amount of time elapsed from an initial timerepresented by the second time stamp to a subsequent time represented bythe first time stamp is greater than a predetermined amount of time,disabling the single use medical device module by programming adisabling bit on the one-time programmable chip; or determining that theOTP component has not been previously programmed, wherein the single usemedical device module is operational.

The single use medical device can include a single use medical devicemodule configured for use within a body of a subject receiving a medicalprocedure. The single used medical device module can include the singleuse feature that disables the single use medical device after the singleuse in a medical procedure. The single use medical device module caninclude an electronic component having a one-time programmable (“OTP”)component that is configured to render the single use medical devicemodule unusable after being used in the medical procedure in thesubject. Once the OTP component is programmed during a single use, theOTP component no longer can be used.

The single use medical device can include a micro image sensor chip suchas a complementary metal-oxide-semiconductor (“CMOS”) chip having anarray of sensor pixels and a plurality of bonding pads disposed alongone or more sides or other areas of the CMOS chip. Alternately oradditionally, the CMOS chip includes row logic, bias, and/or sample andhold components. The OTP component can be operably coupled to orotherwise associated with the CMOS chip so that once the OTP isprogrammed during a single use in a medical procedure, the CMOS chip nolonger is usable.

The electronic component can include one or more of the following: a OTPcomponent electronically coupled with a CMOS image sensor, wherein theOTP component only works one time during a medical procedure, andthereafter it does not allow the single use medical device to operate; aOTP component located on a CMOS image sensor; a OTP component includinga self-sacrificing module (SSM) that self-destructs after being used onetime; a OTP component associated with a timer and an AND circuit, whenthe timer reaches a certain amount of use time, the device no longerworks; a OTP component including a disabling bit (DB) circuit that isprogrammed to disable the single use medical device when a Clock_outsignal is received by the DB circuit; and a OTP component controllingvarious electronic components of the medical device within a disposableportion, and when there is a state change to a single to the OTPcomponent, the disposable portion of the medical device ceases to work.

Accordingly, the present invention generally relates to electronic meansfor inhibiting multiple uses of single-use devices (SUD), such as singleuse medical devices. More particularly, some example embodiments relateto electronic means for using hardware, software, and/or mechanicalschemes in order to inhibit multiple uses of single-use video probes orendoscopes. This electronic means can include a combination ofelectronic hardware and firmware to disable the SUDs after single usagewith a patient. In particular this invention is applied to single-usevideo probes or endoscopes having the disabling electronic means on theprobe or endoscope portion.

In one embodiment, an endoscope can include a micro image sensor chip onthe portion of the endoscope that is inserted within a body of asubject. For example, the micro image sensor chip can be a CMOS chiphaving an array of sensor pixels and a plurality of bonding padsdisposed along one side of the of the CMOS chip. Alternately oradditionally, the CMOS chip can include row logic, bias, and sample andhold components. The micro image sensor chip can include an electroniccomponent that disables the micro image sensor chip from functioningonce it has been used. As such, the micro image sensor chip can includea self-destructing electronic component.

In one embodiment, a self-destructing electronic component can includean OTP logic or circuitry block component being embedded in the sensorchip. The OTP component can have many different implementations. In oneexample, the OTP can include a nonvolatile memory, with bits allocatedto store a system Time Stamp (TS) and bits to store an ID such as theCase ID (CID). One bit is used as the Disabling Bit (DB). When thedisable bit is “flip” or “burned” or “blown” the CMOS sensor will bepermanently disabled. TS and CID can be programmed one time by thesystem controller before being permanently disabled.

In one embodiment, a combination of electronic hardware, firmware and/ormechanical means can be included in the disposable portion of a medicaldevice and configured to disable the disposable portion after a singleusage for a single patient. For instance, example embodiments can beapplied to single-use video probes or endoscopes. More particularly,some embodiments include an endoscope with a micro image sensor chip.

FIG. 1 includes a schematic diagram of an embodiment of a medical device100 that includes a reusable portion 102 (e.g., base) and a single useportion 104 (e.g., scope). The device 100 of FIG. 1 illustrates anexample endoscopic device 100 in which some embodiments can beimplemented. The endoscopic device 100 includes a handle 102 (e.g.,base) and a single use medical device (“SUD”) 104 (e.g., scope)implemented as a disposable catheter 104 or single-use video probe 104.

In some embodiments, the endoscopic device 100 can be configured to behand-held and/or battery-operated. The endoscopic device 100 can includea self-contained reusable handle 102 that includes electronic componentsconfigured for functioning in a medical procedure on its own power,which can include a power source 180, such as rechargeable or disposablebatteries. The power source 180 may also be configured to be pluggedinto a power outlet before and/or during a medical procedure.

The disposable catheter 104 can include a camera and lens assembly 106disposed on, in or near a distal end 108 of the SUD 104. With combinedreference to FIGS. 1 and 2, the camera and lens assembly 108 can includea sensor PCBA 116 that includes a CMOS image sensor 110 mounted on aminiature printed circuit board (“PCB”) 112 with one or more additionalelectronic components. The electronic components can include single useelectronic components, such as a one-time programmable (“OTP”) chip 114.

The PCB 112 with CMOS image sensor 110 and an OTP chip 114 arecollectively referred to herein as a sensor PCB assembly (“sensor PCBA”)116. Although the OTP chip 114 is illustrated in FIG. 2 as beingincluded in the PCBA 116 near the CMOS image sensor 110, in otherembodiments the OTP chip 114 is included in or near the connector 126 ofthe disposable catheter 104. In fact, the OTP chip 114 can be located onany portion of the SUD 104. Also, the OTP chip 114 may be located in thehandle 102, and may be associated with the system controller module(“SCM”) 120, batteries 180 or other electronic component so that onceprogrammed, the OTP chip 114 renders the handle 102 inoperable.

The OTP chip 114 can have one bit or multiple bits representing, forinstance, a time stamp (“TS”) indicating a specific time when thedisposable catheter 104 is first used in a medical procedure, a patientcase ID (“CID”), or the like, as indicated at the bottom of FIG. 2. TheTS and CID stored in the OTP chip 114 uniquely associate the disposablecatheter 104 with a time of first use and a patient ID for which thedisposable catheter 104 was used. Optionally, a status bit, e.g., adisabling bit, is also included in the content of the OTP chip 114.

In the illustrated embodiment of FIG. 1, the disposable catheter 104further includes a flexible or rigid tube 118 within which the cameralens assembly 108 is mounted. The camera lens assembly 108 iselectrically connected to the SCM 120 within the handle 102 viaelectrical lines (e.g., wires, traces, etc.) 122, 124 within the tube118 and handle 102. Optionally, the disposable catheter 104 includesconnector 126 at a proximal end 128 of the tube 118 that iscomplementary to connector 130 of the handle 102. The connectors 126,130 collectively provide a mechanical and electrical interface betweenthe disposable catheter 104 and the handle 102. The connectors 126, 130further provide for easy attachment and detachment of the disposablecatheter 104 from the handle 102 in some embodiments.

According to some embodiments, the electrical lines 122, 124 between thesensor PCBA 116 and the SCM provide for a data path and a control path,including power supply (VDD and VSS) to the sensor PCBA 116 and/or LED,clock (“CLK”), single-ended analog output line and/or double-endeddifferential analog output lines. Optionally, control signals are sharedamong one or more of electrical lines 122, 124. Optionally, theendoscopic device 100 includes an integrated video display 131. Datarepresenting images obtained by the CMOS image sensor 110 is providedover electrical lines 122, 124 and output to the integrated videodisplay 131. Alternately or additionally, the data representing theimages obtained by the CMOS image sensor 110 can have an output 182configured to be operably coupled to an external video display. It isunderstood that the integrated video display 131 is not required in allembodiments.

Referring to FIG. 2, in some embodiments, the SCM 120 includes amicrocontroller unit (“MCU”) 132 or other control module (e.g.,controller, microcontroller, processor, microprocessor, or the like), adigital signal processor (“DSP”) 134, a Boot read-only memory (“ROM”) orflash memory 136, and/or a volatile or non-volatile storage device 138such as an SD card or the like.

In general, the SCM 120 can write once to the OTP chip 114 and readmultiple times from the OTP chip 114. Alternately or additionally, theSCM 120 reads and changes registers on the CMOS image sensor 110 to, forinstance, disable the CMOS image sensor 110 by changing its registers.However, various other functions can be performed to program the OTPchip 114 as being used so that it no longer can be used. This allows theSCM 120 to read the OTP chip 114 before a use, and then either proceedif the OTP chip 114 has not been programmed or used, or terminate orcease functioning if the OTP chip 114 has been programmed or used.

In operation, at power on or reset, the SCM 120 boots from “boot code”stored in the Boot ROM/Flash 136. In some embodiments, the BootROM/Flash 136 also stores firmware for operating the endoscopic device100 and implementing one or more of the methods described herein.Generally, the content in the Boot ROM/Flash 136 is read-only such thatthe content cannot be changed or modified by users of the endoscopicdevice 100.

Accordingly, FIG. 2 provides a schematic diagram of an embodiment ofelectronic components of the medical device of FIG. 1. The illustratedembodiment is a hand-held battery-operated endoscope device 100 wherethe camera and lens assembly 106 disposed on, in or near a distal end108 of the SUD 104. For example, the camera and lens assembly 106 caninclude a CMOS sensor 110 is mounted on a miniature PCB module 112 (the“SM” module) with some minimal components including passives components.The camera module assembly 106 is mounted inside a tube 118 that isflexible or rigid. The camera module assembly 106 is connected to thesystem controller PCB Module 120 (the “SCM” module) inside the handle102, through an easy attach and detach interface connector 130, 126. SCM120 and SM 112 are connected through data path and control path whichinclude power supplies (VDD, VSS) to SM and LED, clock (CLK),single-ended analog output line or double-ended differential analog outlines 122,124. Control signals may be shared among these wires 122, 124.

In some embodiments, the CMOS chip 110 is included within a disposableneedle or flexible catheter (the “Catheter”) and can be used on asingle-use basis. As such, the sterilization process associated withmany multiple-use endoscopes and the risk of infection is eliminated.Moreover, the small size of the CMOS chip 110 facilitates trulyminimally invasive procedures and real-time images suitable for use withdiagnostic and surgical applications according to some embodiments.

In one embodiment, the present invention provides means and methods thatare designed to prevent a single-use catheter or SM from being reused orbeing capable of being reused. In other words, a combination of softwareand hardware mechanisms can use a CMOS sensor that is disabled after oneuse and cannot be reused.

FIG. 3 includes a flow diagram of an embodiment of a process of a singleuse medical device that inhibits reuse of the single use medical device.FIG. 3 describes the OTP implementation of the components of FIG. 2 inthe SUD 104 of FIG. 1. With additional reference to FIG. 3, one exampleof a method 140 of operating the endoscopic device 100 of FIG. 1 orother devices is disclosed. According to some embodiments, the method140 generally determines that a component, such as a catheter or othermedical device component, including the sensor PCBA 116 has already beenused, and should therefore be disabled, if the OTP chip 114 of thesensor PCBA 116 has been programmed or burned more than a predeterminedtime (e.g., Δt minutes) prior to checking the OTP chip 114.

In the discussion that follows, the method 140 will be discussed in thecontext of a disposable catheter 104 including a sensor PCBA 116 thatcan be implemented with the handle 102, with the understanding that themethod 140 can be applied using other components that include sensorPCBAs 116 and/or that are implemented in devices other than the handle102. It should also be understood that a similar method can beimplemented with the handle 102 to render the handle a single usedevice. In fact, the principles described herein with the OTP can beapplied to any medical device or to any portion of any medical device.

In some embodiments, the method 140 of FIG. 3 begins after a clinicianor other healthcare provider opens a sterile package containing acomponent, such as a disposable catheter 104 or other component,including a sensor PCBA 116, and snaps the disposable catheter 104 ontothe handle 102 via connectors 126, 130. At 142, the handle 102 ispowered on or reset, e.g., in response to the clinician pushing a poweron/reset button. At step 144, the SCM 120 is booted and initialized fromboot ROM/Flash 136. At step 146, a Patient ID is obtained. The PatientID corresponds to a patient on whom a medical procedure is to beperformed using the endoscopic device 100. The Patient ID in someembodiments is obtained in response to the clinician scanning anelectronic medical record (“EMR”) corresponding to the patient ormanually entering the Patient ID using an appropriate input device suchas a keyboard connected to the handle 102 or some base of the medicaldevice that includes a controller. At step 148, the SCM 120automatically generates a Case ID (“CID”) corresponding to the PatientID. The CID is generated according to predefined rules. Alternately oradditionally, step 148 further includes obtaining a time stamp (“TS”)representing a current time.

In some embodiments, various other steps are executed after orsimultaneously with step 144 in association with the sensor PCBA 116.Specifically, at step 150, the SCM 120 initializes the sensor PCBA 116including the CMOS image sensor 110, and at step 152, the SCM 120 checksthe OTP chip 114 (e.g., in any location, whether the handle, base,scope, or other) to then determine at step 154 whether the OTP chip 114has ever been programmed. If the OTP chip 114 has never been programmed,indicating that the disposable catheter 104 has never been used, the OTPchip 114 is programmed at step 156 with the CID and TS obtained duringstep 148. On the other hand, if the SCM 120 determines at step 154 thatthe OTP chip 114 has previously been programmed, indicating that thedisposable catheter 104 has been in use previously, a previouslyprogrammed CID′ and previously programmed TS′ will already be stored inthe OTP chip 114 and are output by the OTP chip 114.

At step 158, the SCM 120 determines whether the CID obtained at step 148is identical to the previously programmed CID′ output at step 154. Ifthe CID and CID′ are identical at step 158, then the SCM 120 determinesat step 160 whether the OTP chip 114 was programmed less than apredetermined Δt minutes prior to checking the OTP chip 114 at step 154.Specifically, in some embodiments, the SCM 120 evaluates at step 160whether |TS−TS′|<Δt.

If the SCM 120 determines at step 158 that the CID and CID′ areidentical and if the SCM 120 determines at step 160 that the amount oftime elapsed since the OTP chip 114 was first programmed with TS′ isless than the predetermined time Δt, the procedure continues at step 162until completion at step 164. Alternately, if the SCM 120 determines atstep 158 that the CID and CID′ are not identical, indicating that thepatient on whom the disposable catheter 104 is being used is differentthan a patient on whom the disposable catheter 104 was used previously,or if the SCM 120 determines at step 160 that the amount of time elapsedsince the OTP chip 114 was first programmed with TS′ is greater than thepredetermined time Δt, then at step 166 the SCM 120 disables the sensorPCBA 116 including CMOS image sensor 110 and optionally alerts theclinician that the sensor PCBA 116 has been disabled and/or should notbe used.

In some embodiments, the predetermined time Δt is 120 minutes, or othersuitable time.

According to some embodiments, the method 140 ensures that a single-usemedical device including a sensor PCBA 116 can only be used on a singlepatient during a single procedure.

FIG. 4 includes a schematic diagram of an embodiment of a medical device100A that includes a reusable portion 102 and a single use portion 104.The medical device 100A can be represented as an endoscopic device 100Athat includes features of the endoscopic device 100 described above withrespect to FIGS. 1-3 where like components are identified using likereference numbers. However, the reusable portion 102 can be configuredto be a single use base by using the OTP chip and OTP methods describedherein.

In contrast to the endoscopic device 100 of FIG. 1, however, theendoscopic device 100A of FIG. 4 includes a disposable catheter 104Awithout an OTP chip 114 (FIG. 2). For example, the camera and lensassembly 106A includes a sensor PCBA 116A that lacks an OTP chip 114.Additionally, the endoscopic device 100A includes an SCM module 120Awhich may or may not be configured similarly to the SCM 120 of FIGS. 1and 2, the SCM module 120A generally providing control of the endoscopicdevice 100A.

Furthermore, the endoscopic device 100A includes a self-sacrificingmodule (SSM) 168, rather than an OTP chip 114, for ensuring thedisposable catheter 104 is not used more than once or on more than onepatient. In this regard, and as shown in FIG. 5, the SCM 120A of theendoscopic device 100A is configured to supply a digital clock (“CLK”)170 to drive the components (e.g., a CMOS image sensor) of the PCBA116A. So long as the digital clock 170 is provided to the components ofthe PCBA 116A, the components continue to function.

In some embodiments, the CLK signal 170 and/or a ground are providedover two of electrical lines 122 (FIG. 4), such as over a CLK line 122Aand a ground (“GND”) line 122B, to the PCBA 116A. The SSM 168 includes aswitch 172 coupled between the CLK line 122A and GND line 122B. Innormal operation, the switch 172 is open. However, by closing the switch172 or otherwise connecting the CLK line 122A to the GND line 122B, theCLK signal 170 is destroyed and a relative flat output 174 is created inplace of the CLK signal 170. Without receiving the CLK signal 170, thecomponents of the PCBA 116A are disabled. Thus, the SSM 168 can be OTPby closing the switch 172, which is essentially programming the SSM 168,which thereby may be considered to be an OTP.

FIG. 6 includes a schematic diagram of an embodiment self-sacrificialcomponent 168 of a single use medical device. In particular, FIG. 6discloses aspects of the SSM 168 module in more detail, the SSM 168being configured to automatically close the switch 172 in response tothe disposable catheter 104A of FIG. 4 being subjected to asterilization procedure such as soaking in fluid or exposing to ionizingradiation or by being used. The left side of FIG. 6 is an explodedperspective view and the right side of FIG. 6 is a cross-sectional viewof the SSM 168. As seen in FIG. 6, the SSM 168 includes a conductive pad176A, 176B coupled to each of the CLK line 122A and GND line 122B. Aconductive plate 178 is biased against sacrificial rods 181 towardsconductive pads 176A, 176B by a biasing mechanism 182. The biasingmechanism 182 includes a base 182A and compressed spring 182B (e.g.,biasing element). The sacrificial rods 181 include a Teflon composite orother suitable material such that when soaked in fluid or exposed toionizing radiation, the sacrificial rods 181 dissolve or disintegrate.Upon disintegration/dissolution of the sacrificial rods 181, the biasingmechanism 182 urges the conductive plate 178 against conductive pads176A, 176B to close the circuit between the CLK line 122A and GND line122B.

As shown in FIG. 6, the SSM 168 can be configured to disintegrate andcollapse when exposed to ionizing radiation. Alternatively, the SSM candissolve and collapse when soaked in a fluid, such as an acidic solutionor other solution that degrades the SSM, such as the sacrificial rods orend caps or other features. The material that is degradable candetermine the fluid to use for degradation, where the fluid can be acleaning fluid or sterilization fluid. For example, when the device maybe cleaned or sterilized in a cleaning fluid or sterilizing fluid, amaterial that degrades under the cleaning fluid or sterilizing fluid canbe selected for the SSM. In some instances starches or water solublepolymers may be used that dissolve in water. In any event, degradablematerials can be used that can be degraded by fluids, whether liquid orgas.

In view of the foregoing, FIGS. 4, 5, and 6 describe and illustrateseveral different methods for disabling the CMOS sensor in a SUD 104.FIGS. 7 and 8 illustrate other examples of a sensor PCBA 116B, 116C thatcan be implemented in the disposable catheter 104 of FIG. 1 or othersingle-use medical devices according to some embodiments.

FIG. 7 includes a schematic diagram of an embodiment of a single useprinted circuit board 116B and corresponding signals. In the example ofFIG. 7, the sensor PCBA 116B includes the CMOS image sensor 110 and OTPchip 114 mounted on the PCB 112, and further includes a timer 184 and anAND circuit 186. The timer 114 is coupled to the OTP chip 114, and theOTP chip 114 is coupled to one of the inputs of the AND circuit 186. Aninput clock from the SCM 120 is coupled to the other input of the ANDcircuit 186. The output of the AND circuit 186 is coupled to the CMOSimage sensor 110.

As shown in FIG. 7, one example of system operation in a procedure isdescribed. In summary a catheter or SM is considered as used if its OTPis programmed (or “burned”) longer than a preset Δt minutes ago. The Δtparameter can be adjusted by the manufacture and stored in the boot ROMfor SCM controlled by the manufacture so it cannot be changed bysoftware or other means during the operation.

The medical procedure can be performed as described. The clinician opensthe sterile package and gets the single-use catheter and snaps thecatheter to the handle. The system is turned on by pushing the power onbutton. The system will first boot up the SCM from boot ROM or FLASH.The clinician scans in or manually enters the Patient ID into thesystem. The system will automatically generate a Case ID (CID) from thePatient ID according to a predefined rules (stored in the ROM) such as astring truncated from the Patient ID string. CID and Patient ID shouldhave a one-to-one relationship. At the same time, the SM module isinitialized after SCM initialization. The system checks and reads theOTP from the CMOS, if the OTP has never been programmed, then it meansthis module has not been used. If it has been used, the OTP shouldcontain a CID′ and TS′. The (CID′) from the OTP is compared to the CIDgenerated from the Patient ID. If they are identical and the Time Stamp(TS′) indicates that the OTP was programmed less than (Δt) minutes ago(for instance 60 minutes ago), then it is considered for the samepatient in the same procedure. Upon completion of the procedure, the OTPDB bit will be programmed (burned) to permanently disable the sensor.

In the case that the CID generated from the SCM does do not match theCID′ or TS′ indicates that OTP was programmed at least Δt minutes ago,the CMOS sensor will be disabled by a programming (burn) DB bit of theOTP. The SCM will alert the clinician that the catheter or SM should notbe used.

In the example of FIG. 8, the sensor PCBA 116C similarly includes theCMOS image sensor 110 and OTP chip 114 mounted on the PCB 112, andfurther includes timer 184 and circuit 186. The timer 184 is coupled tothe OTP chip 114, and the OTP chip 114 is coupled to one of the inputsof the AND circuit 186. A sensor output from the CMOS image sensor 110is coupled to the other input of the AND circuit 186. The output of theAND circuit 186 provides data output to the SCM 120.

In either of the examples of FIG. 7 or 8, the content of the OTP chip114 may be one bit, e.g., a disabling bit (“DB”). The timer 184 ispre-programmed to run a predetermined length of time before programmingthe DB bit of the OTP chip 114. Once the DB bit of the OTP chip 114 isprogrammed (or pulled logically “low”), the Clock_out signal to the CMOSimage sensor 110 is disabled in the example of FIG. 7, or the Video_outsignal to the SCM 120 is disabled in the example of FIG. 8.

In the example of FIG. 7 or 8, and in operation, the timer 184 starts torun when a system including the sensor PCBA 116B, 116C is powered on.The time out (Time_Out) to trigger the OTP DB bit can be programmedaccording to various procedures. In some embodiments, sensor PCBAs 116B,116C are color coded according to the corresponding Time_Out value. Forinstance, sensor PCBAs 116B, 116C may be green, blue or yellow forTime_Out values of 30 minutes, 60 minutes, or 90 minutes, respectively.The Time_Out of each sensor PCBA 116B, 116C is hard wired orpreprogrammed and cannot be changed by the user.

According to some embodiments, the timer 184 memory is non-volatile.Thus, if a system including the sensor PCBA 116B, 116C is shut down orotherwise powered off, the elapsed time up to that point would be savedin non-volatile memory and when the system is powered back on, the timer184 would continue its count from the value stored in the nonvolatilememory. For example, if the system is powered off after 15 minutes ofbeing powered on and then powered back on at a later time, the timerwill continue its count from 15 minutes up until reaching Time_Out.

Accordingly, FIGS. 1-8 disclose various schemes for disabling adisposable catheter 104 or other SUD including a CMOS image sensor toensure it is only used a single time. The schemes disclosed herein areprovided by way of example only and should not be construed to limit theinvention. For instance, in some embodiments, after determining that aSUD including a CMOS image sensor has been used previously on adifferent patient, or during a different procedure, or the like, usingan OTP chip or other suitable means, the SUD can be disabled bysupplying a high voltage to the CMOS image sensor to thereby “fry” theCMOS image sensor. Particularly, for a SUD that normally uses a 3.3 voltpower supply, the SUD could be disabled by switching the 3.3 volt powersupply to a 30 volt power supply, which would permanently disable theCMOS image sensor included in the SUD.

In one embodiment, a single use medical device can include a sensormodule that is designed to be only capable of being used by having anOTP component on the SUD. In one aspect, a system controller can bedesigned to include the capability to program the OTP with a system timestamp and an ID generated from Patient ID. In one aspect, the systemcontroller can be designed to read a serial number of the electronicsmodule in the SUD, such as a sensor PCBA, and the system controller canthen tag it or embed the serial number into patient records. In oneaspect, an algorithm can be used to detect and/or determine if anelectronic module, such as a sensor PCBA, has been used and how long ithas been used. In one aspect, the after a single used, the SUD isconfigured to shut down a sensor PCBA and disable it permanently so thatthe SUD is inoperable. In one aspect, a method to shut down a SUD thathas a CMOS image sensor can include disabling the CMOS image sensorpermanently using high voltage.

FIG. 9 includes a diagram of an embodiment of electronic components ofthe medical device of FIG. 1, where the schematic diagram illustrateselectronic components in the reusable portion and electronic componentsin the single use portion. As shown, the SCM 120 includes amicrocontroller unit (“MCU”) 132 or other control module (e.g.,controller, microcontroller, processor, microprocessor, or the like), adigital signal processor (“DSP”) 134, a Boot read-only memory (“ROM”) orflash memory 136, and/or a volatile or non-volatile storage device 138such as an SD card. The sensor PCBA 116 includes a PCB 112 having a CMOSchip 110 that includes therewith an OTP chip 114. In general, the SCM120 can write once to the OTP chip 114 and read multiple times from theOTP chip 114. Alternately or additionally, the SCM 120 reads and changesregisters on the CMOS image sensor 110 to, for instance, disable theCMOS image sensor 110 by changing its registers.

In operation, at power on or reset, the SCM 120 boots from “boot code”stored in the Boot ROM/Flash 136. In some embodiments, the BootROM/Flash 136 also stores firmware for operating the endoscopic device100 and implementing one or more of the methods described herein.Generally, the content in the Boot ROM/Flash 136 is read-only such thatthe content cannot be changed or modified by users of the endoscopicdevice 100.

With combined reference to FIGS. 1 and 9, the camera and lens assembly108 includes a CMOS chip 110 mounted on a miniature printed circuitboard (“PCB”) 112 with one or more additional components such aspassives. An OTP component 114 is embedded in the CMOS chip 110. The PCB112 with CMOS chip 110 and one or more additional components arecollectively referred to herein as a sensor PCB assembly (“sensor PCBA”)116. As disclosed at the bottom of FIG. 9, the content of the OTPcomponent 114 may include one more bits representing, for instance, atime stamp (“TS”) indicating a specific time when the disposablecatheter 104 is first used, a patient case ID (“CID”), or the like. TheTS and CID stored in the OTP component 114 uniquely associate thedisposable catheter 104 with a time of first use and a patient.

According to some embodiments, the electrical lines 122, 124 between thesensor PCBA 116 and the SCM provide for a data path and a control path,including power supplies (VDD and VSS) to the sensor PCBA 116 and anLED, clock (“CLK”), single-ended analog output line and/or double-endeddifferential analog output lines. Optionally, control signals are sharedamong one or more of electrical lines 122, 124.

The CMOS chip 110 containing a OTP component 114, whether implemented ina disposable catheter 104 or other SUD, is configured to be permanentlydisabled after a single use to prevent the disposable catheter 104 orother SUD from being capable of being reused. As such, the sterilizationprocess associated with many multiple-use devices and the risk ofinfection is substantially eliminated according to some embodiments.Moreover, the small size of the CMOS chip 110 facilitates trulyminimally invasive procedures and real-time images suitable for use withdiagnostic and surgical applications according to some embodiments.

FIG. 10 illustrates an embodiment of computer processing for the CMOSchip 110 of FIG. 9, and additional details regarding an exampleembodiment of the CMOS chip 110 are disclosed. In the illustratedembodiment, the CMOS chip 110 includes the OTP component 114.Additionally, the CMOS chip 110 includes a pixel array 140, an analogblock 142, clock 144, digital control 146, and power on reset (“POR”)block 148.

The OTP component 114 can be one bit or multi-bit. The OTP bits contentcan be as shown. The OTP component 114 can control one or more of thecomponents of the CMOS chip 110 as shown by the arrows. The OTPcomponent 114 can be programmed by one or several or all of the variouswell known OTP chip programming, such as but not limited to a pin goingoff chip, digital logic, power-on-reset, or the like.

FIGS. 11, 12, and 13 disclose several different methods for disablingthe CMOS chip 110 using the OTP component 114. In FIG. 11, for example,the output clock (“Clock_out”) of the clock 144 depends on an inputclock (“Clock_in”) from the SCM 120 (FIGS. 1 and 9) and an output fromthe OTP component 114. After the disabling bit DB of the OTP component114 is programmed, Clock_out is turned off and the CMOS chip 110 ispermanently disabled.

In the example of FIG. 12, after the disabling bit DB of the OTPcomponent 114 is programmed, a D_en signal is turned off and the CMOSchip 110 is permanently disabled. In both of FIGS. 11 and 12, the OTPcomponent 114 is controlled from off-chip, e.g., from the SCM 120 (FIGS.1 and 9).

In the example of FIG. 13, the OTP component 114 is programmed bydigital control 146 in response to a particular digital input code.After the disabling bit DB of the OTP component 114 is programmed,Clock_out is turned off and the CMOS chip 110 is permanently disabled.For example, a particular pattern of digital input code can result in anOTP state change. If input code is “01100110” at serial input, thedigital control logic will turn on OTP_ctrl bit, which results in OTPbit flip from 0 to 1, and disables the clock. Other similar bit flipprotocols can be implemented.

With combined reference to FIGS. 1 and 9-13, one example of a method ofa system operation to disable a medical device after a single use isdisclosed. The method may be implemented by the endoscopic device 100,including disposable catheter 104 or other SUD device having, e.g., aCMOS chip 110 containing an OTP component 114. According to someembodiments, the method generally determines that a SUD component suchas a disposable catheter 104 or other component including the CMOS chip110 has already been used, and should therefore be disabled, if the OTPcomponent 114 of the CMOS chip 110 has been programmed or burned morethan a predetermined Δt minutes prior to checking the OTP component 114.Optionally, a parameter can be programmed by the manufacturer and storedin the boot ROM/Flash 136 of the SCM 120 to prevent the parameter frombeing changed by software or other means during operation.

In the discussion that follows, the method will be discussed in thecontext of a disposable catheter 104 including a CMOS chip 110containing a OTP component 114 that can be implemented with the handle102, with the understanding that the method can be applied using othercomponents that include CMOS chips 110 containing OPT components 114and/or that are implemented in devices other than the handle 102.However, any electronic module in the handle 102 or the disposablecatheter 104, or any other component may include the OTP component sothat the specific component or entire system is only operable for asingle use.

In some embodiments, the method begins after a clinician or otherhealthcare provider opens a sterile package containing a component suchas a disposable catheter 104 or other component including a CMOS chip110, and snaps the disposable catheter 104 onto the handle 102 viaconnectors 126, 130. The handle 102 is powered on, e.g., in response tothe clinician pushing a power on button. The SCM 120 is booted from bootROM/Flash 136. A Patient ID is obtained that corresponds to a patient onwhom a medical procedure is to be performed using the endoscopic device100. The Patient ID in some embodiments is obtained in response to theclinician scanning an electronic medical record (“EMR”) corresponding tothe patient or manually entering the Patient ID using an appropriateinput device such as a keyboard connected to the handle 102.

The SCM 120 automatically generates a Case ID (“CID”) corresponding tothe Patient ID. The CID is generated according to predefined rulesstored in, e.g., the boot ROM/Flash 136 in some examples. Optionally,the predefined rules specify truncating a string from a correspondingPatient ID string to generate the CID. In some embodiments, a one-to-onerelationship exists between the Patient ID and the Case ID. Alternatelyor additionally, the method includes obtaining a time stamp (“TS”)representing a current time.

In some embodiments, various other steps are executed after and/orsimultaneously in association with the sensor PCBA 116. Specifically,the SCM 120 initializes the sensor PCBA 116 including the CMOS chip 110,and the SCM 120 checks the OTP component 114 from the CMOS chip 110 tothen determine whether the OTP component 114 has ever been programmed.If the OTP component 114 has never been programmed, indicating that theCMOS chip 110 has never been used, the OTP component 114 is programmedwith the CID and TS obtained.

On the other hand, if the SCM 120 determines that the OTP component 114has previously been programmed, indicating that the CMOS chip 110 hasbeen previously programmed, the previously programmed CID′ andpreviously programmed TS′ will already be stored in the OTP component114 and are output by the OTP component 114. The CID obtained andgenerated from the Patient ID is compared to the previously programmedCID′ output. If the CID and CID′ are identical, then it is determinedwhether the OTP component 114 was programmed less than a predeterminedtime. Prior to checking the OTP component 114, the SCM 120 evaluateswhether |TS−TS′|<Δt. In some embodiments, the value of Δt is 60 minutes,although the value of Δt may alternately be more or less than 60minutes.

If it is determined that the CID and CID′ are identical and if it isdetermined that the amount of time elapsed since the OTP component 114was first programmed with TS′ is less than the predetermined time Δt,the procedure continues until completion. After completion of theprocedure, the disabling bit DB of the OTP component 114 is programmed(burned) to permanently disable the CMOS chip 100.

Alternately, if it is determined that the CID and CID′ are notidentical, indicating that the patient on whom the CMOS chip 110 isbeing used is different than a patient on whom the CMOS chip 110 wasused previously, or if it is determined that the amount of time elapsedsince the OTP component 114 was first programmed with TS′ is at leastthe predetermined time Δt, then the CMOS chip 110 is disabled by aprogramming (burn) of the disabling bit DB of the OTP 114. Optionally,the clinician is alerted that the disposable catheter 104 and/or CMOSchip 110 have been disabled and/or should not be used.

In some embodiments, the predetermined time Δt is 120 minutes, or othersuitable time.

According to some embodiments, the method ensures that a single-usemedical device including a CMOS chip 110 containing a OPT component 114can only be used on a single patient during a single procedure.

Accordingly, a disposable medical device module can be prepared that hasan embedded OTP component on it for single use application. The modulecan include a system controller designed to program the OTP with one ormore of the following: with system time stamp; with an ID generated fromPatient ID; and a dedicated control signal. The module can include asystem controller designed to read the serial number of the electronicsmodule such as a sensor PCBA and ability to tag it or embedded intopatient records. The module can include an algorithm configured todetect and/or determine if an electronic module such as a CMOS chip hasbeen used during a procedure. Various methods can be used to disable theCMOS chip, such as by disabling the clock (CLK) to the CMOS chip usingthe embedded OTP component, disabling the digital enabling D_en insidethe CMOS chip, changing the state of the OTP component by “self-destroy”codes, or the like

The endoscopic device can include a handle and a disposable componentthat is removably attachable to the handle. The disposable component caninclude a CMOS chip with an embedded one-time programmable chip. Amethod of operating the endoscopic device to prevent multiple uses ofthe disposable component can include: generating a first unique caseidentifier corresponding to a first unique patient identifier of apatient undergoing a medical procedure; obtaining a first time stamprepresenting a current time; determining that the one-time programmablechip has previously been programmed with a second unique case identifierand a second time stamp; when the first unique case identifier isdifferent than the second unique case identifier, or when the amount oftime elapsed from an initial time represented by the second time stampto a subsequent time represented by the first time stamp is greater thana predetermined amount of time, disabling the CMOS chip by programming adisabling bit on the one-time programmable chip.

In one embodiment, the disabling bit on the onetime programmable chipdisables a clock (CLK) required for operation by the CMOS chip.Optionally, programming the disabling bit on the one-time programmablechip disables a digital enabling D_en signal within the CMOS chip. Inone aspect, the disabling bit on the one-time programmable chip isprogrammed in response to receiving a “self-destroy” code within theCMOS chip.

It should be recognized that the OTP component, whether a module orchip, or embodied as a SSM, can be used in any component. The OTPcomponent can be coupled to include in or otherwise associated with anyelectronic component that is required for operation so that electroniccomponent can be shut off after the OTP component records a single use.Thus, the handle or base as well as the catheter can become a single usedevice or single use system.

It should also be recognized that the system or components, such as thebase, handle, catheter, or other may be configured to have differentmodes, such as a test mode and a use mode. This can allow for testing ofthe system or components without tripping the OTP or causing the OTP tobe programmed to render the system or components unusable after atesting procedure.

FIG. 6A shows another embodiment of a self-sacrificing module (SSM) 200that self-destructs when subjected to certain conditions, such as thoseconditions that occur during cleaning or sterilization (e.g.,re-cleaning or re-sterilization) after a use (e.g., use in a medicalprocedure). The SSM 200 includes a top cap 202 that is made from amaterial that changes state or becomes compromised upon being exposed toa condition that occurs during cleaning or sterilization. The top cap202 is on a module housing with a base 206 and a spring element 208 witha bottom cap 204 that is biased against the base 206 and top cap 202.Once the top cap 202 is exposed to the condition, the top cap 202degrades. Once the top cap 202 degrades past a certain threshold,usually during a cleaning or sterilization, the spring element 208causes the top cap 202 to break apart or break off of the housing. Oncethe top cap 202 is broken, currently no longer can pass through the SSM200, and thereby the system or device having the SSM is no longeroperational. As such, the top cap 202 can be configured such that anycleaning or sterilization causes degradation and breaking. Thereby,after use of the system or component and during the attempt to clean orsterilize, the top cap 202 will break, and the SSM 200 will no longerallow the system or device to operate. Thus, the SSM provides aself-destruct mechanism. The bottom cap 204 may be configured similarlyor different from the top cap 204, and both the bottom cap 204 and topcap 202 can be prepared from a material that degrades upon cleaning orsterilization.

In one embodiment, the SSM includes the top cap 202 and/or bottom cap204 being degradable to one or more substances, where both the top cap202 and bottom cap 204 may be degradable by the same substances or bydifferent substances. As such, a substance used in one cleaning orsterilization technique may only degrade the top cap 202, and asubstance used in another cleaning or sterilization technique may onlydegrade the bottom cap 204. Thus, a first cleaning or sterilizationtechnique can be used and then the other cleaning or sterilizationtechnique can be used before degradation causes activation of the SSMand disabling of the device. Also, the top cap 202 and/or bottom cap 204may be independently configured to degrade after a certain number ofcleaning or sterilization cycles, such as 1, 2, 3, 4, 5, 6, 7, 8, 19,10, or other integer. In an example, the certain number of cleaning orsterilization cycles that degrades one or both caps and activates theSSM to disable the system is 2, which allows for one cleaning orsterilization cycle during manufacture and packaging, and then the nextcleaning or sterilization cycle activates the SSM to disable the system.In one example, the cap element can at least partially degrade duringthe first sterilization cycle (e.g., manufacturing or packaging), whichcan lead to the increment of a counter (e.g., OPT module) upon detectionof the open or closed circuit of the SSM. Upon booting up the device,the counter state is read, and if only one count is determined by thecounter state the device boots. If the device is re-sterilized aftermanufacture, either the first SSM further degrades or a second parallelSSM would be activated so as to increment the counter again, such as asecond count. Upon boot, the software would read an impermissible countnumber (e.g., 2) and either fail to boot entirely or put up a splashscreen indicating the device is not operable. Accordingly, the SSM canbe degraded in stages, where the stages can be detected by the SCMand/or programmed into the OTP, and once the defined number of stages isreached (e.g., 2 for a single use device or other integer for a devicethat can be used multiple times), the SSM is activated and the system isrendered inoperable. In another aspect, there can be two or more SSMs inparallel for a given line (e.g., signal, data, power etc.), and thenonce all of the SSMs (or defined number of SSMs) are activated, thesystem is rendered inoperable as described herein (e.g., will not boot).

In one embodiment, there can be different SSMs that degrade underdifferent cleaning or sterilization compositions or conditions. Whendifferent initial sterilization methods are used, such as EtO (ethyleneoxide) initially and, for example, gamma to re-sterilize, the EtOsensitive SSM would initially degrade and become activated, and thenupon re-sterilization, the gamma sensitive SSM would degrade and becomeactivated. Here, the device or system still functions after the EtOtreatment, but does not does not function (e.g., is renderednon-functional) upon re-sterilization with gamma radiation. Accordingly,different detectors can be in a single SSM for each modality of a singleSSM for each modality.

In another embodiment, when gamma is used in both sterilizationprocesses, the thickness of the end caps (e.g., top cap or bottom cap)or other features of the housing or other degradable components, and/orthe springs within the SSM can be adapted so that the SSM can surviveone cleaning or sterilization cycle, but is the SSM is activated duringthe second cleaning or sterilization cycle. As such, the SSM would notsurvive two cycles, and would be disabled upon the second cycle. In thisaspect, the counter would be useful for counting the cleaning orsterilization cycles so that the system or device is programmed tobecome inoperable as soon as the count is reached (e.g., 1, 2, 3, 4, 5,6, or other integer as the count to disablement).

In one aspect, in order for the SSM 200 of FIG. 6A to operate, it ispresumed that attempts will be used to re-sterilize and thereby reusethe one-time use devices described herein. For various reasons,especially including patient safety and prevention of the spread ofinfectious agents, mechanisms and methods are included with the devicesto detect and prevent re-use. As such, the SSM 200 can be included inany medical device to render that medical device a single use device orSUD.

In one example, the top cap 202 may be made of a material sensitive toheat, fluid, and/or irradiation. In addition, the bottom cap 204 canalso be made of a sensitive material, permitting one SSM 200 to activatein response to more than one cleaning/sterilization modality.

The role of the SSM is to provide a physical and/or electrical responseto an attempt to clean or re-sterilize the medical device that includesthe SSM. The SSMs may work independently, rendering the device havingone or more SSMs inoperable upon activation, or they may communicatewith the OTP module to indicate that they have been triggered oractivated, or they may do a combination of both. As shown in FIG. 6A,the arrows show data or electrical directions that can be coupled to theOTP module, and thereby upon destruction of the SSM, the OTP module canbe set and defined as having already been used in a medical procedure sothat the device having the SSM and/or OTP module may not be used again.In the first instance, the activation of an SSM causes a change in theelectrical characteristics of the SSM, which in of itself causes thedevice having the SSM to fail to operate. In the second instance, thechange in the electrical characteristics of the SSM is seen as a statechange by the medical device software or firmware, and this state changethen leads to alternative code execution, which in some manner preventsusage. The code can instruct the SCM to not operate or to not operatewith the catheter. The code may also instruct the MCU, boot ROM/flash,DSP, or volatile or non-volatile storage device to not operate. The codemay also instruct the CMOS sensor to not operate.

In one embodiment, the SSM can include a mechanism which is normallyconductive to electricity (e.g., module housing and/or base 206), butupon activation becomes non-conductive, leading to an open circuit. Suchactivation can be by the chemicals often used during cleaning orsterilization. If the ground of the system or component, or even theoverall design of the device, is appropriately routed through the SSM,then upon activation of the SSM and destruction of the ability toconduct current therethrough and creation of an open circuit, electricalpower will no longer be available to the device and it will fail toboot.

An SSM 200 which meets the characteristics necessary to prevent reusefollowing re-sterilization using gamma irradiation is shownschematically in FIG. 6A. In its intact, or non-activated state, currentmay flow through the device, such as shown by the arrows or in theopposite direction. However, if the top cap 202 is made of a polymerthat becomes frangible, and thereby loses a portion or the majority ofits strength upon irradiation, the spring 208 can be selected with astiffness constant such that after irradiation the top cap 202 breaksoff, thereby prohibiting current flow through the SSM 200. For example,polyacetal is a plastic material that can be used for the top cap 202.

In one example, if the user attempts to clean or re-sterilize themedical device by using a cycle that involves an elevated temperature,such as steam sterilization, then the SSM 200 of FIG. 6A can beconstructed such that the top cap 202 is made of a low temperaturemelting polymer, thereby causing the spring 208 to rupture or otherwisedestroy the top cap 208. For example, ABS is one such plastic that canbe used for the temperature sensitive top cap 208.

Accordingly, an SSM 200, which is sensitive to both irradiation andheat, may be constructed by making one top cap 202 of a polymersensitive to irradiation, and another portion of the SSM, such as thebottom cap 204 sensitive to heat. Alternatively, a device may containindependent irradiation and heat SSMs 200, or only contain one or theother.

The SSM may be fabricated such that an end cap (e.g., top cap 202 orbottom cap 204) or part of an end cap readily dissolves upon theintroduction of an aqueous fluid. Upon attempts to re-sterilize a devicehaving one or more SSMs, such as by using a liquid method, the SSM maydissolve upon the introduction of an aqueous fluid. The soluble portionof the end cap may be contained with an end cap already sensitive toirradiation or heat, or the entire end cap may be made from a solublematerial. Combinations of materials sensitive to heat, dissolution,and/or irradiation may be used as needed to provide the intendedprotection against re-use. This provides the ability to make the devicehaving the SSM a single use device.

An alternative configuration of the SSM 200A for detecting immersion inliquid (e.g., aqueous fluid) is by creating a reservoir 210 between twoconductors 212A, 212B, such as shown in FIG. 6B. Accordingly, duringwashing the aqueous fluid is trapped in the reservoir 210 between thetwo conductors 212A, 212B, thereby changing the resistance orcapacitance of a portion of the circuit in the SSM 200A. This change inresistance or capacitance is by the aqueous fluid or other liquidgetting trapped in the reservoir, and which can be determined by the SCMor other controller. Accordingly, the change in the resistance orcapacitance of the SSM 200A can be read by the operating system or SCMas an impermissible event, and cause the OTP module to be programmed,thereby leading to the inability to use the device again.

In one embodiment, an OTP chip (e.g., circuit) can be used inconjunction with an SSM when detecting the medical device has beenthrough an EtO (ethylene oxide) sterilization cycle. EtO is a chemicalthat can be used for providing terminal sterility to the medical devicewithout irradiation, heat, or fluid to activate the SSMs that aresusceptible thereto, which may also be present. Accordingly, a sensorthat is sensible to the presence of EtO gas can be incorporated withinthe circuit. Such EtO sensors are known and may be developed in thefuture, and such EtO sensors can be included in the system or anycomponent thereof, such as in any medical device portion that may besterilized by EtO. As an example, FIG. 6B could be used to describe suchan EtO sensitive SSM, where the element 210 may represent such a EtOsensor. Upon sterilization with EtO during manufacture and productpackaging, the EtO sensor's state may change from “0” to “1” and thisvalue is read on the subsequent boot of the medical device, for example,during a surgical procedure. This value of “1” is stored in non-volatilememory. If the EtO gas sensor in the SSM detects a subsequent EtOsterilization cycle, the counter is incremented to “2.” The medicaldevice operating code is written such that a value of “2” in the cyclecount bit indicates that it should not operate. This allows the systemto be designed to allow for manufacturing sterilization, but not forpost-manufacturing sterilization after use in a medical procedure.However, it should be recognized that the OTP component can beprogrammed with the EtO sensor state so that the OTP performs the singleuse functionality to render the single use medical device moduleunusable after being used in the medical procedure in the subject.

An alternative methodology of allowing for initial terminalsterilization with irradiation during manufacturing, while preservingthe ability of an SSM to subsequently detect an irradiation cycle afteruse in a medical procedure is to create the top cap (e.g., 202) of theSSM (e.g., 200) of the appropriate size, thickness, or shape such thatone irradiation cycle of 2.5 to 4.0 MRad of gamma irradiation isinsufficient to cause the top cap to fail, but two cycles, or acumulative dose of 5.0 to 7.5 MRad, is sufficient to cause failure ofthe top cap (or bottom cap or other end cap). In this manner, no cyclecount circuit is required. Also, any sterilization cycle (e.g., EtOsterilization cycle) count greater than zero would indicate an attemptto reuse the medical device after having already been used. Thus,various methodologies can be used to make the medical device a singleuse device.

It should be recognized that not all modalities of detection of reuseneed be present in one medical device. The developer may pick and chooseSSMs and their ability to ensure the medical device is a single usedevice that can only be used in a single medical procedure. Thedifferent SSM modules may be wired in series, in parallel, orindependently as dictated by the designer's intent and user needs.

It should be recognized that the OTP component, whether a module orchip, or embodied as a SSM, can be used in any component. The OTPcomponent can be coupled to include in or otherwise associated with anyelectronic component that is required for operation so that electroniccomponent can be shut off after the OTP component records a single use.Thus, the handle or base as well as the catheter can become a single usedevice or single use system.

As described herein, it should be recognized that a handle or base caninclude the SCM. The SCM is configured to provide power, processingelectronics and software that drives the single use device (SUD). Often,the SUD is a catheter or other medical device that is utilized in orwith the body of a patient such that the medical device would need to besterilized prior to an additional use. Also, the SUD is oftenoperatively coupled with the SCM (e.g., coupled to handle or base havingthe SCM) in order to use the SUD and then attached therefrom after use.The SUD is often operably coupled with the SCM and controlled by the SCMto function. The OTP modules and SSM modules described herein can beincluded in the medical device to prevent that medical device from beingreused after first single use.

FIG. 9A shows an alternative to the OTP SUD content. As such, the statusbit(s) can be bits or connections for the clock, power, or signal lines.As such, the OTP can disable any of these, such as clock, power, orsignal lines, and thereby disable any component that is operably coupledwith the clock, power, or signal line. Accordingly, the SSMs can beintegral to the operation of the OTP module by either providing anelectrical connection when the SSM is intact, or providing no connectionwhen the SSM has been activated and degraded so that there is no longeran electrical connection. Also, the status bit can be programmed, suchas “New” or “Used.” When programmed as “New” the medical device can beused. When reprogrammed after a use in a medical procedure to “Used,”the medical device cannot be used. This provides single usefunctionality to the medical device.

Additionally, FIG. 3A provides an alternative operational protocolcompared to FIG. 3. FIG. 3A shows that the SUD is attached to the SCM,and then the SCM initializes the SUD, where the SCM reads the statusbit(s) of the OTP module in the SUD. When the status bit(s) are read as“Used”, then the SCM implements a procedure to notify the user that thestatus of the SUD is “Used.” Here, it should be noted that the bit(s)that are read as used may be physically burned or fused such that theymay not be reprogrammed. However, it is possible that more complexprogramming of the OTP module may be available. The OTP module may haveone or more bits that can only be programmed a single time withoutreprogramming, and such programming can provide an indication of used.That is, the first programming of the OTP module, such as by burning orfusing a bit, can result in the SCM subsequently reading the OTP moduleas indicating the device has been “Used.” Once the single bit isprogrammed (e.g., burned or fused), it cannot be changed again. When theOTP module has multiple bits, each bit can be programmed once, whichallows for a multi-use device or allows for sterilization or operationduring testing before packaging and shipping to be sold. This allows thenumber of bits in the OTP module to be tailed for the total number ofuses, including test uses or actual uses. Accordingly, the number ofbits may be “n”, which can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or otherinteger, and one or more of such bits may be identified as testing bitsso that they do not count as a use, and other bits may be identified asuse bits so that they do count as a use. After the first use bit isprogrammed (e.g., burned or fused), the SCM will read the OTP module asbeing “Used” as shown in FIG. 3A. Also, the programming of the OTP maybe by programming a single bit or a set of bits. When the status bitsare changed, the SCM can read the status bits as “Used”. When there isan attempt to reuse the device, the SCM will check the status bit(s) andprogram other bits (e.g., open, fuse, short, blown lines for example)that would permanently disable the SUD. Accordingly, the SUD is labeledto be “Used” in the first stage, it is disabled in the second stage. Thenotification of “Used” may also be accompanied by beeps or other audioindicators as well as the display providing graphical information towarn the user that the SUD has already been used. Once identified as“Used,” the SCM can program the OTP module with the bits (e.g., “burn”or “fuse”) such that the connections of the clock, power, or signal willbe opened or shorted to render the SUD unusable. This can have theconsequences of the SCM and/or SUD being permanently disabled (e.g.,usably destroyed) such that reuse of the SCM and/or SUD is prevented.

Also, when a first use in a medical procedure, the stats read by the SCMmay not be “Used” (e.g., no), then the SCM can program the status bit(s)to “Used.” Then, once the medical procedure is finished, the SUD can bedetached from the SCM, and upon such detachment the SCM can program theOTP to identified it has been used so that the SCM and/or SUD ispermanently disabled. For example, upon disconnection after a medicaluse, the SUD can automatically program the OTP bits to “Used” so thatthe SUD is permanently disabled and prevented from being reused.

In an example, during a first use of the SUD, the OTP module may beprograms with status bits to indicate it is being used. Then the secondtime the SUD is attempted to be used additional status bits areprogrammed and the device turns off and cannot be used. This canpermanently disable the SUD upon a second attempted use.

All of the SSM mechanisms (e.g., chemical heat, radiation etc.) triggerthe second stage, i.e., disable SSM, SUD permanently.

It should also be recognized that the system or components, such as thebase, handle, catheter, or other may be configured to have differentmodes, such as a test mode and a use mode. This can allow for testing ofthe system or components without tripping the OTP or causing the OTP tobe programmed to render the system or components unusable after atesting procedure. Accordingly, there can be a code, such as “test” thatcan be entered into the system or components so that the OTP chip ormodule is not programmed or otherwise caused to be tripped duringtesting. The test mode can allow for increased system or componenttesting and safety prior to being shipped. In one example, the system orcomponent can be programmed with the “test” code during manufacturingand testing, and then the system or component is programmed with a “use”code so that the next use trips the OTP so that this use is a singleuse.

As shown in FIG. 3B, the system can be configured to allow for the testmode and then use mode. Accordingly, the test mode can be different fromthe use mode such that during the test mode the SUD remains usable, butafter a single use in the use mode, the SUD no longer is usable. Assuch, the test mode can be configured so that it does not program theOTP module, whether the OTP module is in the SUD or in the housing orbase having the SCM. Accordingly, the SUD is attached to the housing(e.g., base or handle) that has the SCM, and the SCM initializes theSUD, during which the OTP module in the SUD is checked. If the OTPmodule check fails due to having been previously used in a medicalprocedure, the user is provided with the information that the SUD is nolonger usable, which can be with audible beeps or the display showing awarning to the tester, and thereby the tester knows the OTP module has aproblem, such as would occur if the SUD had already been used. If theOTP module check passes, then the SCM can test other functions of theSUD, such as checking operation of the camera, lights, or the like. Ifthe other functions fail, then the user is provided with the informationthat the SUD is no longer usable, which can be with audible beeps or thedisplay showing a warning to the tester, and thereby the tester knowsthe SUD has a problem and should not be used. If the other functionspass, then the SUD is in good condition to be used in a medicalprocedure. As such, the SUD can only be in good condition if it has notbeen used before and all of the components are indicated to befunctional. This same procedure can be performed on the base or handlethat has the SCM to make sure the SCM has not been used before or isfully functional when the base or handle is designated for only a singleuse.

Accordingly, the SSMs described herein can be implemented so thatactions taken to clean or sterilize the medical device render themedical device nonfunctional. The fuse-like nature of the SSMs can allowcurrent to flow before the SSM is activated, but then become opencircuits so that current cannot flow through the SSM once activated ortripped by a cleaning or sterilization process. This allows theplacement of the SSMs to be in locations upstream from functionalcomponents so that the device cannot function without these functionalcomponents once the SSM is activated. The SSMs can be adapted to beactivated by heat, liquid, radiation, chemical contact, or the like. TheSCM or other controller can read the operational characteristics of theSSM, and once the operational characteristics of the SSM change to aparameter or past a threshold, the SCM or other controller can programthe OTP module so that the device having the OTP module is no longerusable, in accordance with the teachings herein. This allows for thestatus of the SSM to determine whether or not the OTP module isprogrammed to be inoperable. The state of the SSM module can bedetermined by the SCM and then the SCM can program the OTP moduleaccordingly. This allows the SCM and programming of the medical device(e.g., handle, base, catheter etc.) to be tailored to assess the statusof an SSM and then allow operation if the SSM is intact or denyoperation if the SSM is degraded or otherwise activated. Accordingly,the SCM can monitor the SSM in real time, or upon startup or shutdown,and then provide the instructions to program the OTP module.

While not shown, the SUD, such as catheter or other SUD that is usedwith or in a body can include a controller that can perform thefunctions described for the SCM. Accordingly, the content of FIGS. 2,and 5-13 can be included in the SUD and operated as described herein.This can allow the SUD to self-assess the status and determine whetheror not the OTP module should be programmed as used and thereby no longeroperational. Similarly, these figures and operational protocols can beapplied to a handle or base to render the handle or base a single usedevice.

In one embodiment, the SUD medical device can include two or more SSMsalong with instructions as to how to sterilize the SUD prior to thefirst use. One of the SSMs is set to be activated by the instructedsterilization procedure, and then once activated the SSM will cause thesequence of events to program the OTP module as used once the SUD isused in a medical procedure. This can allow for a one time sterilizationprior to use that does not render the SUD unusable, but allows for aspecific sterilization to maintain operability. However, if the otherSSMs are activated by a different type of sterilization or furthersterilization, then the SUD is rendered inoperable by the OTP modulebeing programmed as used.

Similarly, the system or components thereof, including the SUD andhandle or base having the SCM can be configured so that once the SUD iswithdrawn from packaging it is set in a “sterilization mode” that allowsfor sterilization. Once sterilized by a medical professional and thenturned on, the SCM can then perform the procedure so that the SUD can beused one time before the OTP module is programmed to be used. This alsoallows for onsite sterilization before the single use of the SUD withoutcausing the SUD to become unusable before it is used.

In one embodiment, the OTP module and/or SSM can be included in thehandle or base that attaches to the single use medical device. This canallow the handle or base to also be a SUD. For example, in someinstances a medical device or medical device system may be used in ahighly infectious environment (e.g., Ebola, hantavirus, etc.) or highlycontaminating environment, where the handle or base may be exposed tothe infectious agent or contaminant. As such, the ability to make thebase or handle a SUD can increase the safety for the medicalprofessionals and patient. Instead of reusing such a possiblycontaminated base or handle, such base or handle can be disposable afterthe single use. Here, FIG. 1A shows the OTP module 214 to be included inthe handle 102 (e.g., or base). The OPT module 214 can be operablycoupled with the SCM 120, and may also be operably coupled with the MCU132, boot ROM/flash 136, storage medium 138, or DSP 134, as well as anyother component, such as the batteries. This allows the OPT module 214to render the handle 102 inoperable after a single use. Similarly, thehandle 102 and catheter 104 may be integrated and a unitary device,which is a SUD. This integrated SUD may be used and operated asdescribed herein so that it can only be used in a medical procedure asingle time.

In one embodiment, the medical device can be programmed so that the SCMallows for multiple uses before rendering the medical device unusable.As such, the OTP module may be configured to be programmed “n” timesbefore rendering the medical device unusable. Here, “n” can be aninteger, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or other number. Also,the SSM may be configured so that it becomes activated after “n” timesof cleaning or sterilization. As such, instead of a single use medicaldevice, the medical device can be used for a defined number of timesbefore it is rendered inoperable. In one aspect, the defined number ofuses can be stored in the boot ROM/flash memory, other memory, or on thestorage drive. In any event, various configurations commensurate withthe disclosure herein can be implemented to make a medical device with apredefined number of uses, such as the “n” number of uses.

Additionally, the technology is not limited to only medical devices thatare used on a subject, but also to any other device that may bedesirable to be a single use device or a devices with a predeterminednumber of uses. As such, any electronic device can include the OTPcomponent and/or SSM as described herein.

In one embodiment, an electronic device that includes the OPT componentand/or SSM module may be a radio frequency probe (e.g., RF probe). Assuch, devices similar to RF probes or other handheld devices can beconfigured with the single use components that could become inoperableafter a single use, or a re-sterilization protocol. Often, surgicaldevices may have RF identification elements, and an RF probe is used tosend radiofrequency to determine presence of the RF identificationelement. Thus, the RF probe may be suitable for only a single use orpredetermined number of uses and include the OTP component and/or SSM aswell as the methodologies described herein.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

One skilled in the art will appreciate that, for this and otherprocesses and methods disclosed herein, the functions performed in theprocesses and methods may be implemented in differing order.Furthermore, the outlined steps and operations are only provided asexamples, and some of the steps and operations may be optional, combinedinto fewer steps and operations, or expanded into additional steps andoperations without detracting from the essence of the disclosedembodiments.

The present disclosure is not to be limited in terms of the particularembodiments described in this application, which are intended asillustrations of various aspects. Many modifications and variations canbe made without departing from its spirit and scope, as will be apparentto those skilled in the art. Functionally equivalent methods andapparatuses within the scope of the disclosure, in addition to thoseenumerated herein, will be apparent to those skilled in the art from theforegoing descriptions. Such modifications and variations are intendedto fall within the scope of the appended claims. The present disclosureis to be limited only by the terms of the appended claims, along withthe full scope of equivalents to which such claims are entitled. It isalso to be understood that the terminology used herein is for thepurpose of describing particular embodiments only, and is not intendedto be limiting.

In an illustrative embodiment, any of the operations, processes, etc.described herein can be implemented as computer-readable instructionsstored on a computer-readable medium. The computer-readable instructionscan be executed by a processor of a mobile unit, a network element,and/or any other computing device.

There is little distinction left between hardware and softwareimplementations of aspects of systems; the use of hardware or softwareis generally (but not always, in that in certain contexts the choicebetween hardware and software can become significant) a design choicerepresenting cost vs. efficiency tradeoffs. There are various vehiclesby which processes and/or systems and/or other technologies describedherein can be effected (e.g., hardware, software, and/or firmware), andthat the preferred vehicle will vary with the context in which theprocesses and/or systems and/or other technologies are deployed. Forexample, if an implementer determines that speed and accuracy areparamount, the implementer may opt for a mainly hardware and/or firmwarevehicle; if flexibility is paramount, the implementer may opt for amainly software implementation; or, yet again alternatively, theimplementer may opt for some combination of hardware, software, and/orfirmware.

The foregoing detailed description has set forth various embodiments ofthe processes via the use of block diagrams, flowcharts, and/orexamples. Insofar as such block diagrams, flowcharts, and/or examplescontain one or more functions and/or operations, it will be understoodby those within the art that each function and/or operation within suchblock diagrams, flowcharts, or examples can be implemented, individuallyand/or collectively, by a wide range of hardware, software, firmware, orvirtually any combination thereof. In one embodiment, several portionsof the subject matter described herein may be implemented viaApplication Specific Integrated Circuits (ASICs), Field ProgrammableGate Arrays (FPGAs), digital signal processors (DSPs), or otherintegrated formats. However, those skilled in the art will recognizethat some aspects of the embodiments disclosed herein, in whole or inpart, can be equivalently implemented in integrated circuits, as one ormore computer programs running on one or more computers (e.g., as one ormore programs running on one or more computer systems), as one or moreprograms running on one or more processors (e.g., as one or moreprograms running on one or more microprocessors), as firmware, or asvirtually any combination thereof, and that designing the circuitryand/or writing the code for the software and or firmware would be wellwithin the skill of one of skill in the art in light of this disclosure.In addition, those skilled in the art will appreciate that themechanisms of the subject matter described herein are capable of beingdistributed as a program product in a variety of forms, and that anillustrative embodiment of the subject matter described herein appliesregardless of the particular type of signal bearing medium used toactually carry out the distribution. Examples of a signal bearing mediuminclude, but are not limited to, the following: a tangible andnon-transitory recordable type medium such as a floppy disk, a hard diskdrive, a CD, a DVD, a digital tape, a computer memory, etc.; and atransmission type medium such as a digital and/or an analogcommunication medium (e.g., a fiber optic cable, a waveguide, a wiredcommunications link, a wireless communication link, etc.). In oneaspect, the memory device can be tangible and non-transitory, and havecomputer executable instructions stored thereon for processing with acomputer processor.

Those skilled in the art will recognize that it is common within the artto describe devices and/or processes in the fashion set forth herein,and thereafter use engineering practices to integrate such describeddevices and/or processes into data processing systems. That is, at leasta portion of the devices and/or processes described herein can beintegrated into a data processing system via a reasonable amount ofexperimentation. Those having skill in the art will recognize that atypical data processing system generally includes one or more of asystem unit housing, a video display device, a memory such as volatileand non-volatile memory, processors such as microprocessors and digitalsignal processors, computational entities such as operating systems,drivers, graphical user interfaces, and applications programs, one ormore interaction devices, such as a touch pad or screen, and/or controlsystems including feedback loops and control motors (e.g., feedback forsensing position and/or velocity; control motors for moving and/oradjusting components and/or quantities). A typical data processingsystem may be implemented utilizing any suitable commercially availablecomponents, such as those generally found in datacomputing/communication and/or network computing/communication systems.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures can beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected”, or“operably coupled”, to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable”, to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents and/or wirelessly interactable and/or wirelessly interactingcomponents and/or logically interacting and/or logically interactablecomponents.

FIG. 14 shows an example computing device 600 that is arranged toperform any of the computing methods described herein. The computingsystem 600 can represent a user side computing device, such as areusable portion of a medical device or a single use portion of amedical device. The components of the computing system 600 can beincluded in the single use portion of the medical device to facilitate acomputing method that disables the single use portion or single usemedical device. In a very basic configuration 602, computing device 600generally includes one or more processors 604 and a system memory 606. Amemory bus 608 may be used for communicating between processor 604 andsystem memory 606.

Depending on the desired configuration, processor 604 may be of any typeincluding but not limited to a microprocessor (μP), a microcontroller(μC), a digital signal processor (DSP), or any combination thereof.Processor 604 may include one more levels of caching, such as a levelone cache 610 and a level two cache 612, a processor core 614, andregisters 616. An example processor core 614 may include an arithmeticlogic unit (ALU), a floating point unit (FPU), a digital signalprocessing core (DSP Core), or any combination thereof. An examplememory controller 618 may also be used with processor 604, or in someimplementations memory controller 618 may be an internal part ofprocessor 604.

Depending on the desired configuration, system memory 606 may be of anytype including but not limited to volatile memory (such as RAM),non-volatile memory (such as ROM, flash memory, etc.) or any combinationthereof. System memory 606 may include an operating system 620, one ormore applications 622, and program data 624. Application 622 may includea determination application 626 that is arranged to perform thefunctions as described herein including those described with respect tomethods described herein. Program Data 624 may include determinationinformation 628 that may be useful for analyzing the contaminationcharacteristics provided by the sensor unit 240. In some embodiments,application 622 may be arranged to operate with program data 624 on anoperating system 620 such that the work performed by untrusted computingnodes can be verified as described herein. This described basicconfiguration 602 is illustrated in FIG. 6 by those components withinthe inner dashed line.

Computing device 600 may have additional features or functionality, andadditional interfaces to facilitate communications between basicconfiguration 602 and any required devices and interfaces. For example,a bus/interface controller 630 may be used to facilitate communicationsbetween basic configuration 602 and one or more data storage devices 632via a storage interface bus 634. Data storage devices 632 may beremovable storage devices 636, non-removable storage devices 638, or acombination thereof. Examples of removable storage and non-removablestorage devices include magnetic disk devices such as flexible diskdrives and hard-disk drives (HDD), optical disk drives such as compactdisk (CD) drives or digital versatile disk (DVD) drives, solid statedrives (SSD), and tape drives to name a few, which are tangible andnon-transitory storage devices. Example computer storage media mayinclude volatile and nonvolatile, removable and non-removable mediaimplemented in any method or technology for storage of information, suchas computer readable instructions, data structures, program modules, orother data.

System memory 606, removable storage devices 636 and non-removablestorage devices 638 are examples of tangible and non-transitory computerstorage media. Computer storage media includes, but is not limited to,RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM,digital versatile disks (DVD) or other optical storage, magneticcassettes, magnetic tape, magnetic disk storage or other magneticstorage devices, or any other medium which may be used to store thedesired information and which may be accessed by computing device 600.Any such computer storage media may be part of computing device 600.

Computing device 600 may also include an interface bus 640 forfacilitating communication from various interface devices (e.g., outputdevices 642, peripheral interfaces 644, and communication devices 646)to basic configuration 602 via bus/interface controller 630. Exampleoutput devices 642 include a graphics processing unit 648 and an audioprocessing unit 650, which may be configured to communicate to variousexternal devices such as a display or speakers via one or more A/V ports652. Example peripheral interfaces 644 include a serial interfacecontroller 654 or a parallel interface controller 656, which may beconfigured to communicate with external devices such as input devices(e.g., keyboard, mouse, pen, voice input device, touch input device,etc.) or other peripheral devices (e.g., printer, scanner, etc.) via oneor more I/O ports 658. An example communication device 646 includes anetwork controller 660, which may be arranged to facilitatecommunications with one or more other computing devices 662 over anetwork communication link via one or more communication ports 664.

The network communication link may be one example of a communicationmedia. Communication media may generally be embodied by computerreadable instructions, data structures, program modules, or other datain a modulated data signal, such as a carrier wave or other transportmechanism, and may include any information delivery media. A “modulateddata signal” may be a signal that has one or more of its characteristicsset or changed in such a manner as to encode information in the signal.By way of example, and not limitation, communication media may includewired media such as a wired network or direct-wired connection, andwireless media such as acoustic, radio frequency (RF), microwave,infrared (IR) and other wireless media. The term computer readable mediaas used herein may include both storage media and communication media.

Computing device 600 may be implemented as a portion of a small-formfactor portable (or mobile) electronic device such as a cell phone, apersonal data assistant (PDA), a personal media player device, awireless web-watch device, a personal headset device, an applicationspecific device, or a hybrid device that include any of the abovefunctions. Computing device 600 may also be implemented as a personalcomputer including both laptop computer and non-laptop computerconfigurations.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should be interpreted to mean “at least one”or “one or more”); the same holds true for the use of definite articlesused to introduce claim recitations. In addition, even if a specificnumber of an introduced claim recitation is explicitly recited, thoseskilled in the art will recognize that such recitation should beinterpreted to mean at least the recited number (e.g., the barerecitation of “two recitations,” without other modifiers, means at leasttwo recitations, or two or more recitations). Furthermore, in thoseinstances where a convention analogous to “at least one of A, B, and C,etc.” is used, in general such a construction is intended in the senseone having skill in the art would understand the convention (e.g., “asystem having at least one of A, B, and C” would include but not belimited to systems that have A alone, B alone, C alone, A and Btogether, A and C together, B and C together, and/or A, B, and Ctogether, etc.). In those instances where a convention analogous to “atleast one of A, B, or C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (e.g., “a system having at least one of A, B, or C” wouldinclude but not be limited to systems that have A alone, B alone, Calone, A and B together, A and C together, B and C together, and/or A,B, and C together, etc.). It will be further understood by those withinthe art that virtually any disjunctive word and/or phrase presenting twoor more alternative terms, whether in the description, claims, ordrawings, should be understood to contemplate the possibilities ofincluding one of the terms, either of the terms, or both terms. Forexample, the phrase “A or B” will be understood to include thepossibilities of “A” or “B” or “A and B.”

In addition, where features or aspects of the disclosure are describedin terms of Markush groups, those skilled in the art will recognize thatthe disclosure is also thereby described in terms of any individualmember or subgroup of members of the Markush group.

As will be understood by one skilled in the art, for any and allpurposes, such as in terms of providing a written description, allranges disclosed herein also encompass any and all possible subrangesand combinations of subranges thereof. Any listed range can be easilyrecognized as sufficiently describing and enabling the same range beingbroken down into at least equal halves, thirds, quarters, fifths,tenths, etc. As a non-limiting example, each range discussed herein canbe readily broken down into a lower third, middle third and upper third,etc. As will also be understood by one skilled in the art all languagesuch as “up to,” “at least,” and the like include the number recited andrefer to ranges which can be subsequently broken down into subranges asdiscussed above. Finally, as will be understood by one skilled in theart, a range includes each individual member. Thus, for example, a grouphaving 1-3 cells refers to groups having 1, 2, or 3 cells. Similarly, agroup having 1-5 cells refers to groups having 1, 2, 3, 4, or 5 cells,and so forth.

From the foregoing, it will be appreciated that various embodiments ofthe present disclosure have been described herein for purposes ofillustration, and that various modifications may be made withoutdeparting from the scope and spirit of the present disclosure.Accordingly, the various embodiments disclosed herein are not intendedto be limiting, with the true scope and spirit being indicated by thefollowing claims. All references recited herein are incorporated hereinby specific reference in their entirety.

The invention claimed is:
 1. A device comprising: a self-sacrificingmodule (SSM) that is configured to self-destruct and render the deviceunusable upon being cleaned or sterilized; wherein the SSM is operablycoupled to a around electronic line and a clock line, when inactivatedthe SSM does not electronically couple the around electronic line andthe clock line, when activated the SSM electronically couples the aroundelectronic line and the clock line.
 2. The device of claim 1, whereinthe SSM is operably coupled with one or more electronic components inthe device.
 3. The device of claim 2, wherein the SSM is operablycoupled with a system controller module (SCM).
 4. The device of claim 1,wherein the SSM is operably coupled to a ground electronic line.
 5. Thedevice of claim 1, wherein the SSM is located within an electroniccircuit of the device and activation of the SSM causes an electroniccircuit to open or close to render the device unusable.
 6. The device ofclaim 1, the SSM comprising a biasing mechanism including a biasingelement and first and second electrically conductive elements spacedapart by the biasing element, when the SSM is inactivated the firstelectrically conductive element does not electronically couple with thesecond electrically conductive element, when the SSM is activated thebiasing element electronically couples the first electrically conductiveelement with the second electrically conductive element.
 7. The deviceof claim 6, the SSM comprising a degradable member positioned betweenthe first electrically conductive element and the second electricallyconductive element, when the degradable member degrades, the biasingelement electronically couples the first electrically conductive elementwith the second electrically conductive element.
 8. The device of claim7, wherein the degradable member degrades in response to heat,ionization, chemicals, liquid, aqueous solution, or radiation.
 9. Thedevice of claim 1, the SSM comprising an electrically conductivedegradable member positioned between and electrically coupling a firstelectrically conductive element and a second electrically conductiveelement, when the conductive degradable member degrades, the firstelectrically conductive element electrically uncouples with the secondelectrically conductive element.
 10. The device of claim 9, the SSMcomprising a biasing element biased against the electrically conducivedegradable member, when the SSM is activated the biasing element breaksthe electrically conductive degradable member so that the firstelectrically conductive element is not electrically coupled with thesecond electrically conductive element.
 11. The device of claim 9,wherein the electrically conductive degradable member degrades inresponse to heat, ionization, chemicals, liquid, aqueous solution, orradiation.
 12. The device of claim 1, the SSM comprising an electricallyconductive member having an electrically conductive state and anelectrically non-conductive state, the electrically conducive memberbeing positioned between and electrically coupling a first electricallyconductive element and a second electrically conductive element, whereinthe electrically conductive member changes from the electricallyconductive state to the electrically non-conductive state when exposedto a chemical, when in the electrically non-conductive state the firstelectrically conductive element is electrically uncoupled from thesecond electrically conductive element.
 13. The device of claim 1,wherein the device is a handle or a base that is operably coupleable toa single use medical device module configured for use within a body of asubject receiving a medical procedure.
 14. The device of claim 1,wherein the device is a single use medical device is configured for usewithin a body of a subject receiving a medical procedure.
 15. Anendoscope comprising a single-use portion configured for insertion intoa patient and a reusable portion to which the single-use portion isdetachably attached to form said endoscope, comprising: electroniccomponents that are in said single-use portion of the endoscope and areconfigured to image a field of view in a patient while the single useportion is being used in a patient procedure; and a self-sacrificingmodule (SSM) that is in said single-use portion of the endoscope and isconfigured to respond to an attempt to sterilize the single use portionafter use thereof in a patient procedure by automatically preventingoperation of said electronic components to thereby render the single-useportion unusable for a patient procedure; wherein said SSM comprises aclock line configured to supply clock pulses to said electroniccomponents and a switch responsive to said attempt to sterilize todisable said clock line and thereby deprive said electronic componentsof said clock pulses and make the electronic components non-functional.16. The endoscope of claim 15, in which said SSM comprises a conduitsupplying operating power to said electronic components and the switchresponsive to said attempt to sterilize to disable said conduit andthereby deprive said electronic components of said operating power andmake them nonfunctional.
 17. The endoscope of claim 15, in which saidattempt to sterilize comprises subjecting the single-use portion tosterilization by ionizing radiation.
 18. The endoscope of claim 15, inwhich said attempt to sterilize comprises subjecting the single-useportion to sterilization by fluid.
 19. The endoscope of claim 15, inwhich said attempt to sterilize comprises subjecting the single-useportion to sterilization by heat.
 20. The endoscope of claim 15, inwhich said attempt to sterilize comprises subjecting the single-useportion to sterilization by ethylene oxide.
 21. The endoscope of claim15, in which said SSM is further configured to respond to a secondattempt to sterilize said single-use portion but not to a first attemptto sterilize.
 22. A method of using an endoscope made of a single-useportion configured for insertion into a patient and a reusable portionto which the single-use portion is detachably attached to form saidendoscope, said method comprising: introducing said single-use portioninto a patient and imaging a field of view in the patient during amedical procedure using electronic components in said single-useportion; and causing a self-sacrificing module (SSM) in said single-useportion to automatically respond to an attempt to sterilize the singleuse portion after use thereof in said medical procedure by automaticallypreventing operation of said electronic components to thereby render thesingle-use portion unusable for a patient procedure; wherein said SSMcomprises a clock line configured to supply clock pulses to saidelectronic components and a switch responsive to said attempt tosterilize to disable said clock line and thereby deprive said electroniccomponents of said clock pulses and make the electronic componentsnon-functional.